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Guidance for China Reach: data collection on terrestrial organism test

The background

The China New Chemical Substance Notification (China Reach), ever since it was launched, has been increasingly stringent on the testing data provided in the notification dossiers. It is frequently learned from many cases where the notifiers themselves confused with the certain data requirements according to the regulation, which has different levels towards different tonnage band of chemicals. For most notifiers, particularly those from outside China, the data collection has inevitably posed a big threat for continued manufacture or exportation. The problem is enlarged as the regulation is now taken more seriously by the authority and in essence caused by the lack of knowledge and tidings ever generated from the law enforcement body—CRC-MEP.

In an interview, recently, with the top officials in CRC-MEP, conducted by experts from REACH24H Consulting Group China, suggests specifics to heed for the data collection in line with requirements under China Reach. The information can be very useful due to its source and chiefly roots deep in the regular notification when the data requirements is set to be more complex, the result more unpredictable, as has been shown in numerous ‘return cases’ where the data in the dossier unable to tackle the one last, and probably the hardest challenge—the expert review.

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Lowest threshold in data collection

In China Reach, there are three sets of data ought to be filled in the notification dossiers. These include the physicochemical data, toxicological data and eco-toxicological data, among which only some part of the eco-toxicological data must be generated through experiments done by the accredited laboratory in China, i.e., data acquired from laboratories outside China, however highly recognized internationally, is invalid for the use in China Reach dossier data preparation.

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The eco-toxicological data provided by the accredited laboratory in China has its lowest threshold which the following three units of data must be included in the dossier: ready biodegradability, acute toxicity in aquatic organism and acute toxicity in terrestrial organism. Concerning that most chemicals tend to be dissolved in water, the acute toxicity in terrestrial organism is, among all three basic data required, alone none-compulsory. Questions very often rise when certain notified chemical is labeled as insoluble compound (water solubility<100 mg/l)?who has more remarkable toxicological impact on terrestrial organism over aquatic organism, under which circumstance, the experiment on acute toxicity in terrestrial organism becomes a must to be carried out within Chinese territory, i.e., by any of the 9 currently accredited laboratories authorized by MEP.

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What the CRC-MEP has to say

Quotes from the CRC-MEP top officials during the interview thereby confirms ‘the test of acute toxicity in terrestrial organism must be carried out in the accredited laboratory in China, if the chemical has its dissolubility lower than 100 mg/L, while, the testing data of the acute toxicity in aquatic organism, acquired if not in China but in foreign laboratory, is allowed to be adopted, with one basic prerequisite that the foreign laboratory being accredited GLP laboratory’. Meanwhile, the following circumstance that ‘for all the chemicals with dissolubility higher than 100 mg/L, namely the dissolved chemicals, the test of acute toxicity in aquatic organism must be conducted in China, and with no such compulsory request that the corresponding test of acute toxicity in terrestrial organism should be done in China only’.

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In recent years, though the regulation emerged and grew quickly, the professional research upon China Reach remains at infancy. The regular contact with enforcement body still counts as one important and efficient way of obtaining information from nowhere else you might.

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About REACH24H

The REACH24H is a China-based consulting firm, specializing in providing chemical regulatory consultancy, agency and technical support. Our main focus covers the major chemical regulations emerged all around the world, such as EU REACH, EU CLP, China Reach, China GHS, etc. We aims at assisting chemical manufacturers, importers and downstream users to effectively meet the chemical regulatory obligations as well as remove chemical regulatory barriers to their business. In recent years, our services have expanded to a larger extent with cutting-edge IT solution provided and partnerships with globally famous regulatory services providers established, such as WERCS, ChemAdvisor, etc. Our comprehensive cooperation with law enforcement bodies such as the ECHA in EU and CRC-MEP in China, ensure our staying at the forefront of regulatory development, helping us seizing the key to the regulatory affairs and trend.

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